Medtronic MiniMed 630G System

Automated Insulin Dosing , Threshold Suspend

FDA Premarket Approval P150001 S076

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Packaging, labeling, and final release activities of the one-press serter conducted at medtronic, inc. To be moved to contract manufacturer facility. The one-press serter is a component of the 530g system, the 630g system, the 670g system, and the guardian connect system.

DeviceMedtronic MiniMed 630G System
Classification NameAutomated Insulin Dosing , Threshold Suspend
Generic NameAutomated Insulin Dosing , Threshold Suspend
ApplicantMEDTRONIC MINIMED
Date Received2019-10-11
Decision Date2019-11-04
PMAP150001
SupplementS076
Product CodeOZO
Advisory CommitteeClinical Chemistry
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address MEDTRONIC MINIMED 18000 Devonshire St northridge, CA 91325

Supplemental Filings

Supplement NumberDateSupplement Type
P150001Original Filing
S077 2019-10-17 30-day Notice
S076 2019-10-11 30-day Notice
S075 2019-09-30 30-day Notice
S074
S073 2019-08-21 30-day Notice
S072 2019-07-15 30-day Notice
S071 2019-06-19 30-day Notice
S070 2019-06-13 30-day Notice
S069 2019-05-21 30-day Notice
S068 2019-05-17 30-day Notice
S067
S066
S065
S064 2019-04-03 30-day Notice
S063 2019-04-01 30-day Notice
S062 2019-02-25 30-day Notice
S061 2019-02-11 30-day Notice
S060
S059 2019-02-01 30-day Notice
S058 2019-01-22 30-day Notice
S057
S056 2018-11-07 30-day Notice
S055 2018-11-07 30-day Notice
S054 2018-11-02 30-day Notice
S053 2018-10-15 30-day Notice
S052 2018-08-31 Real-time Process
S051 2018-07-23 30-day Notice
S050 2018-07-23 Normal 180 Day Track
S049 2018-07-09 30-day Notice
S048 2018-07-02 30-day Notice
S047 2018-06-19 30-day Notice
S046 2018-06-07 Special (immediate Track)
S045 2018-06-04 30-day Notice
S044 2018-05-11 30-day Notice
S043 2018-03-29 30-day Notice
S042 2018-03-26 30-day Notice
S041 2018-03-12 30-day Notice
S040 2018-02-23 30-day Notice
S039 2018-02-09 Real-time Process
S038 2018-02-07 30-day Notice
S037 2018-01-31 30-day Notice
S036 2018-01-30 30-day Notice
S035 2018-01-29 30-day Notice
S034 2018-01-29 30-day Notice
S033 2018-01-23 Special (immediate Track)
S032 2017-12-22 30-day Notice
S031 2017-11-30 Real-time Process
S030 2017-11-24 30-day Notice
S029
S028 2017-10-30 Normal 180 Day Track
S027 2017-10-30 30-day Notice
S026 2017-10-10 30-day Notice
S025 2017-10-06 30-day Notice
S024 2017-09-29 30-day Notice
S023 2017-09-14 30-day Notice
S022 2017-08-04 Real-time Process
S021 2017-08-02 Panel Track
S020 2017-07-21 Real-time Process
S019 2017-07-17 30-day Notice
S018
S017 2017-06-02 Special (immediate Track)
S016 2017-05-30 30-day Notice
S015 2017-05-08 30-day Notice
S014 2017-04-10 30-day Notice
S013 2017-04-07 Real-time Process
S012 2017-03-31 30-day Notice
S011 2017-03-24 30-day Notice
S010
S009 2016-12-23 Real-time Process
S008 2016-12-14 Normal 180 Day Track
S007 2016-12-12 30-day Notice
S006 2016-11-28 30-day Notice
S005 2016-11-28 30-day Notice
S004 2016-11-02 30-day Notice
S003 2016-10-24 Real-time Process
S002 2016-10-14 30-day Notice
S001 2016-09-02 30-day Notice

NIH GUDID Devices

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